There exists a plurality of medical and/or surgical procedures that are carried out intravascularly or intralumenally. For example, in the treatment of vascular diseases, such as atherosclerosis, percutaneous angioplasty and stenting are now widely accepted procedures.
Such procedures usually involve the percutaneous puncture and insertion of a hollow needle through a patient's skin and muscle tissue into the vascular system. A guide wire is then typically passed through the needle lumen into the patient's blood vessel accessed by the needle. The needle may be removed, and an introducer sheath may be advanced over the guide wire into the vessel, for example, in conjunction with or subsequent to, a dilator.
A catheter or other device may then be advanced through a lumen of the introducer sheath and over the guide wire into position for performing a medical procedure such as, dilating the vessel, stenting of the latter, or the like.
In percutaneous transluminal coronary angioplasty, the catheter is typically introduced either in the radial or femoral artery and advanced through the artery to the coronary region. Catheters typically have a diameter in the range of one millimeter and four millimeters, hence creating a significant puncture in the artery. Also, during the procedure, the catheter may be twisted or otherwise manipulated as it is advanced to the treatment site, hence potentially causing a further enlargement of the puncture.
Upon completion of the procedure, the devices and introducer sheath may be removed, leaving a puncture site in the vessel wall. Such procedures hence unavoidably present the problem of stopping the bleeding at the percutaneous puncture site after the procedure has been completed and after the instrument and any introducer sheaths used therewith have been removed.
At present, such bleeding is sometimes stopped by the application of direct digital pressure over the puncture site by a trained physician or other suitably trained medical personnel. Such direct pressure has to be properly applied for a sufficiently long period of time for hemostasis to occur so that the opening is effectively closed against further bleeding. The application of direct digital pressure over the puncture site, although somewhat useful, nevertheless suffers from numerous drawbacks.
First, the direct digital pressure application procedure constitutes an inefficient, if not wasteful, use of medical professional services. For example, in the case of punctures into relatively high pressure vessels, such as into the femoral artery or superficial femoral arteries, the pressure may have to be applied for as long as forty-five minutes for hemostasis to occur.
Second, the application of digital pressure over a relatively long period of time may result in fatigue, numbness, stiffness and/or pain occurring in the fingers, hands, wrists and/or forearms of the practitioner performing the procedure. Furthermore, repetition of the procedure over a period of time may cause repetitive-type stress injuries, such as carpal tunnel syndrome or the like.
Still furthermore, although the procedure is typically performed with gloves there exists a possibility that the glove could already have, or may develop, a tear, thereby allowing direct pressurized digital contact with potentially contaminating bodily fluids.
Third, it is often difficult for an individual to exert digital pressure of optimal magnitude, especially over a relatively long period of time. The magnitude of the pressure exerted may however prove to be particularly important in some situations. Indeed, should the magnitude of the pressure be suboptimal, a bruise or hematoma may form at the entry site since internal bleeding of the punctured artery continues until clotting blocks the puncture. On the contrary, should the applied pressure be too great, this may result in a substantial reduction, if not virtual arrest, of the flow of blood through the vessel. This, in turn, may lead to thrombosis of the vessel with potentially serious complications.
Yet another drawback associated with the conventional digital application of pressure at the puncture site results from the fact that the instrument and any introducer sheath used therewith is typically completely withdrawn prior to the application of pressure at the puncture site. This results in a brief, yet vigorous, free-flow of blood through the puncture site, which may obscure the exact location of the puncture momentarily leading to further blood loss.
Still furthermore, the conventional method of digital pressure application of the puncture site is sometimes considered uncomfortable for the patient and requires that the patient remain immobilized in the operating room, catheter lab, holding area or the like, hence using up valuable space.
Some styptic devices as been shown in the prior art. However, such prior art devices suffer from numerous drawbacks. Indeed, prior art device generally suffer from being unergonomical to the user and uncomfortable to the patient. Prior art devices also suffer from being overall too complex, and, hence, relatively expensive and potentially unreliable.
Accordingly, there exists a need for an improved styptic device for hemostatically sealing percutaneous vascular punctures. It is a general objective of the present invention to provide such an improved styptic device.